Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2030-12-31

Brief Summary

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Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic stroke patients to improve bimanual activities and motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.

A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for motor learning.

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Detailed Description

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tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in chronic stroke patients with motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during performance of bimanual activities and/or motor learning. A few minutes/hours/days/weeks after completing one trial's arm, the patients will enter the other trial's arm (double-blind cross-over design).

Baseline and follow-up outcomes about bimanual and unimanual motor tasks will be collected.

For a subset of subjects, motor learning and data acquisition will be performed with a neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) .

Conditions

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Stroke Deficit in Manual Activities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

tDCS real versus sham tDCS (this is what this is)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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real tDCS

Patients will receive non-invasive and painless brain stimulation over the brain areas involved in cognitive aptitudes.

tDCS will be applied during 20 minutes while patients will perform motor bimanual tasks

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

Sham tDCS

this will be exactly as for "real tDCS" unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial)

Group Type PLACEBO_COMPARATOR

tDCS

Intervention Type DEVICE

Interventions

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tDCS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• stroke with at least slight deficit

Exclusion Criteria

* epilepsy
* contraindication to tDCS and/or to fMRI
* presence of metal in the head
* inability to understand / complete behavioral tasks
* chronic intake of alcohol or recreational drugs
* major health condition
* presence of pacemaker (for the fMRI part only)
* pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes